The ISO 13485:2016 international standard is relevant to organizations that are involved in the life-cycle of medical devices, be it design and development, production, storage and distribution, installation and servicing, or other relevant activities. If you are working in such an organization, it is important to have a certain level of understanding of this international standard. As such, this knowledge will add valuable credentials to your resume.

Regardless of whether you have attended any ISO 13485 training, this self-assessment test serves as a tool for you to check and validate your knowledge of ISO 13485. Upon completion of the test, you may find yourself lack of knowledge in certain areas or clauses. With this information, you can then focus your learning on these areas or clauses.

The composition of the test includes:

• Clause 1 Scope

• Clause 2 Normative References

• Clause 3 Terms and Definitions

• Clause 4 Quality Management System

• Clause 5 Management Responsibility

• Clause 6 Resource Management

• Clause 7 Product Realization

• Clause 8 Measurement, Analysis and Improvement

Please note that the international standard – ISO 13485:2016 Medical Devices – Quality Management System – Requirements for Regulatory Purpose is a copyright protected document of International Organization for Standardization (ISO). Hence, we are not permitted to share or reproduce for you. Please purchase a copy from ISO store or its authorized stores.